WO2017005332A1 - Procédé pour mesurer une pluralité de paramètres d'état d'un fluide contenu dans un récipient - Google Patents

Procédé pour mesurer une pluralité de paramètres d'état d'un fluide contenu dans un récipient Download PDF

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Publication number
WO2017005332A1
WO2017005332A1 PCT/EP2016/000678 EP2016000678W WO2017005332A1 WO 2017005332 A1 WO2017005332 A1 WO 2017005332A1 EP 2016000678 W EP2016000678 W EP 2016000678W WO 2017005332 A1 WO2017005332 A1 WO 2017005332A1
Authority
WO
WIPO (PCT)
Prior art keywords
sensor
sensors
control unit
container
external control
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2016/000678
Other languages
German (de)
English (en)
Inventor
Mario Becker
Gerhard Greller
Christian Grimm
Thorsten Adams
Lars BÖTTCHER
Henry Weichert
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sartorius Stedim Biotech GmbH
Original Assignee
Sartorius Stedim Biotech GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sartorius Stedim Biotech GmbH filed Critical Sartorius Stedim Biotech GmbH
Priority to CN201680030003.7A priority Critical patent/CN107636138B/zh
Priority to EP16720044.3A priority patent/EP3319727B1/fr
Priority to US15/737,847 priority patent/US10968421B2/en
Publication of WO2017005332A1 publication Critical patent/WO2017005332A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/02—Form or structure of the vessel
    • C12M23/14—Bags
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/50—Mixing receptacles
    • B01F35/513—Flexible receptacles, e.g. bags supported by rigid containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/505—Flexible containers without fluid transport within
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/26—Constructional details, e.g. recesses, hinges flexible
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
    • C12M41/30—Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration
    • C12M41/34—Means for regulation, monitoring, measurement or control, e.g. flow regulation of concentration of gas
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M41/00—Means for regulation, monitoring, measurement or control, e.g. flow regulation
    • C12M41/48—Automatic or computerized control
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00871—Communications between instruments or with remote terminals

Definitions

  • the invention relates to a method for measuring a plurality of
  • Sensor support plate is fixed in a fluid-tight manner, which carries a plurality of sensors, each having a standing in operative contact with the interior of the bioreactor sensor head and communicating with an external control unit in data-communicating communication path,
  • the external control unit receives and processes measurement data generated by the sensor heads of active sensors via their communication link.
  • bioreactor in the form of a disposable bioreactor bag, i. a disposable bioreactor configured bag with flexible
  • the arranged outside the bag sensor part provides the interface to a communication link to an external control unit.
  • This communication link can be designed, for example, as an electrical cable, as a glass fiber cable or wirelessly, for example in the form of a radio or IR link.
  • the sensor and the external control unit are in data-exchanging communication via this communication link so that data generated by the sensor head can be sent to the control unit via the communication link in an analogue or digital manner for further processing.
  • Said document discloses as a mechanical interface as a so-called multi-port a cohesively introduced into the bag wall plate with a plurality of individual breakthroughs into which the sensors required for the specific reaction process are inserted and activated as needed.
  • the step of plugging a sensor into one of the ports is hygienic, i. in aspects of sterility maintenance
  • the disposable containers in question which are available as a bag with flexible wall or as so-called “carboy” container made of plastic with a rigid wall, already manufacturer with disposable sensors, which are non-releasably arranged on a fluid-tight - for example, by material connection, such as gluing or welding, or by suitable non-positive or positive connection - connected to the wall sensor carrier plate.
  • the assembly ie the equipment of an individual bag with an individual compilation different sensors then takes place under hygienically optimized conditions on the part of the bag manufacturer and in each case especially according to customer requirements.
  • Corresponding disposable bioreactor bags are known, for example, from EP 2 503 320 B1. However, this procedure, which is not objectionable from a hygienic point of view, raises economic problems because the individual packaging prevents cost-effective mass production.
  • each sensor is assigned an activation record and stored for the external control unit accessible
  • This method makes it possible to meet the manufacturer's interests in a uniform mass production as well as the customer's interests in individual packaging and a price coupled to the possible uses.
  • the manufacturer offers the possibility of equipping each container with at least partially flexible or rigid walls, eg a bag, with a battery of all sensible sensors in the respective technical context, so that the individual container is more expensive with regard to its sensor equipment, which is, however, complicated by the Cost advantages of uniform mass production overcompensate.
  • the customer receives containers that have only the sensor functionality that they specifically want (and pay for). The individual packaging is therefore no longer on the side of the sensor hardware, but only on the part of the activation software, ie in the design of the activation records instead.
  • a first user who requires only one or a few sensors for his particular bioreaction or mixing process receives the same container, e.g. As a bag, with identical sensor equipment as a second user who requires a very extensive sensor technology for its bioreaction or mixing process. He buys to his container, z. But adds only one or a few sensor activation licenses, and pays a correspondingly lower price than the second user, who must purchase a variety of sensor activation licenses.
  • the activation records for the individual sensors can be made accessible to the external control unit in different ways. It is thus possible to provide each container with an individual data carrier, which can then be read by the external control unit. Alternatively, it is also possible for the users to receive the activation data records in other ways and to have them stored directly in the external control unit. Of particular interest, however, is the
  • Activation records centrally on a - in particular operated by the manufacturer - server to which users have access to a network, such as the Internet. Regardless of the particular way in which the activation data records are made available, it is necessary, as the person skilled in the art recognizes, to make the bags or sensors individually recognizable, but this can be done in any manner known in various embodiments. By way of example, the use of transponders, RFI D chips, barcodes, QR codes, etc. may be mentioned.
  • At least one non-activated sensor does not acquire measured data. This can, for example. be done by the fact that the corresponding sensor from the external control unit not required for its operation supply, eg an electrical
  • Energy supply receives.
  • optical sensors can be provided that the corresponding sensor receives no measurement light from an external light source.
  • the sensor carrier plate will be provided with a central energy and / or measuring light supply, so that non-activated sensors are able to work.
  • the non-activated sensors are working, but the measurement data generated by them are not transmitted to the external control unit.
  • the non-activation in this case thus relates to the communication path between the sensor and the external control unit.
  • this type of activation or non-activation does not work either.
  • the external control unit receives measurement data from at least one non-activated sensor but does not process it.
  • the activation or non-activation of the sensor thus takes place here in the external control unit. All of the aforementioned activation or non-activation strategies have in common that the user does not receive data from the non-activated sensors.
  • the container is designed as a disposable mixing container or a disposable bioreactor, each with at least partially flexible wall.
  • the disposable bioreactor is designed as a bag.
  • the container is designed as a disposable mixing container or a disposable bioreactor, each with at least partially rigid wall, also known in the art under the name "Carboy”.
  • the communication path of a sensor can be designed as a radio link, an electrically conductive cable, as a fiber optic cable or in some other way.
  • a plurality of electrically conductive cables and / or a plurality of communication links designed as optical fiber cables are combined in a standardized collective cable.
  • reusable cable can be used.
  • Figure 1 a schematic representation of the method according to the invention. Detailed description of preferred embodiments
  • Figure 1 shows a schematic representation of the basic operation of the method according to the invention. Shown are two identical containers with flexible wall, for example disposable bioreactor bags or disposable mixing containers 10, 10 '.
  • the container 10 shown on the left in FIG. 1 carries the individual identifier symbolized as "Buvw”, and the container 10 'shown on the right in FIG. 1 carries the individual identifier symbolized as "Bxyz”.
  • This identifier can be realized in plain text, as a barcode, as a QR code, as a transponder, as an RFID chip or in a similar manner. It is essential that the identifier can be read by an external control unit 12 so that the containers 10, 10 'can be individually recognized.
  • Both containers 10, 10 'carry an identically embodied sensor field 14, 14' which comprises a carrier plate connected fluid-tight to the wall of the respective container 10, 10 'and sensors S01-S10 or S01'-S10' fixedly connected to the carrier plate.
  • This data-transmitting connection can be individually from each sensor S01-S10, S01'-S10 'to the external control unit 12 or via a plurality of sensor inputs / outputs
  • sensors S01-S10, S01-S10 ' are wired via optical fibers or electrical conductors and others of the sensors S01-S10, S01'-S10' are wirelessly connected to the external control unit 12.
  • the sensors S01-S10, S01'-S10 ' are in contact with the interior of the respective container 10, 10' with their sensor heads not shown separately, so that state parameters of a fluid contained in the container 10, 10 'can be measured with them.
  • the external control unit 12 has, as by the
  • Communication arrow 20 indicated, access to a database 22 in which bag-individual activation records 24, 24 'for the sensors S01-S10, S01 -S10' are deposited.
  • the containers buvw (10), which is designed for example as a bag, the sensors S03 and S05 deposited as activated, whereas the other sensors, S01, S02, S04 and S06-S10 are deposited as not activated. In FIG. 1, this is indicated by "+" or "-" signs in the activation data record 24 and by full or empty representation of the sensors in the sensor field 14.
  • the sensors SOt, S04', S06 ', S07' and S10 ' are deposited as activatable, whereas the sensors S02', S03 ', S05', S08 'and S09 'are deposited as not activatable.
  • the representation in the activation data set 24 'and in the sensor field 14' is
  • the external control unit To carry out measurements with the sensor fields 14, 14 ', the external control unit first accesses the activation data records 24, 24' and then activates for each container 10, 10 'only those sensors which are deposited there as activatable. Of the other, as not activatable deposited sensors, the user gets no measurement data provided. It does not matter at which point the sensor blockage occurs. As already discussed in the general part of the description, this can be done at the level of the sensor head, at the level of the communication link to the external control unit or in the external control unit itself. One skilled in the art will understand that this method has a broad spectrum of

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Sustainable Development (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Computer Hardware Design (AREA)
  • Hematology (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
  • Arrangements For Transmission Of Measured Signals (AREA)

Abstract

L'invention concerne un procédé permettant de mesurer une pluralité de paramètres d'état d'un fluide contenu dans un récipient (10, 10'), une plaque de support de capteur étanche aux fluides étant fixée sur la paroi du récipient (10, 10') configuré à usage unique, cette plaque de support de capteur étant pourvue d'une pluralité de capteurs (S01-S10, S01'-S10') qui présentent respectivement une tête de détection en contact fonctionnel avec l'intérieur du récipient (10, 10') et une voie de communication en contact de façon à échanger des données avec une unité commande externe (12), l'unité de commande externe (12) recevant via la voie de communication des données de mesure générées au moyen des têtes de détection de capteurs actifs (S03, S05; S01', S04', S06', S07', S10') et traitant celles-ci. L'invention est caractérisée en ce qu'un jeu de données d'activation (24, 24') est associé à chaque capteur (S01-S10, S01'-S10') et est stocké de manière accessible pour l'unité de commande externe (12) et en ce que l'unité de commande externe (12) accède ensuite aux jeux de données d'activation (24, 24'), classe les capteurs (S01-S10, S01'-S10') en suivant des règles prédéfinies sur la base des différents jeux de données d'activation (24, 24') associés à chaque capteur en tant que capteurs pouvant être activés ou capteurs ne pouvant pas être activés, puis active ensuite uniquement les capteurs classés comme pouvant être activés (S03, S05; S01', S04', S06', S07', S10').
PCT/EP2016/000678 2015-07-06 2016-04-27 Procédé pour mesurer une pluralité de paramètres d'état d'un fluide contenu dans un récipient Ceased WO2017005332A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CN201680030003.7A CN107636138B (zh) 2015-07-06 2016-04-27 用于测量包含在容器中的流体的多个状态参数的方法
EP16720044.3A EP3319727B1 (fr) 2015-07-06 2016-04-27 Procédé pour mesurer une pluralité de paramètres d'état d'un fluide contenu dans un récipient
US15/737,847 US10968421B2 (en) 2015-07-06 2016-04-27 Method for measuring a plurality of parameters of state of a fluid contained in a container

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102015110894.1 2015-07-06
DE102015110894.1A DE102015110894B3 (de) 2015-07-06 2015-07-06 Verfahren zum Messen einer Mehrzahl von Zustandsparametern eines in einem Behälter enthaltenen Fluids

Publications (1)

Publication Number Publication Date
WO2017005332A1 true WO2017005332A1 (fr) 2017-01-12

Family

ID=55910202

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2016/000678 Ceased WO2017005332A1 (fr) 2015-07-06 2016-04-27 Procédé pour mesurer une pluralité de paramètres d'état d'un fluide contenu dans un récipient

Country Status (5)

Country Link
US (1) US10968421B2 (fr)
EP (1) EP3319727B1 (fr)
CN (1) CN107636138B (fr)
DE (1) DE102015110894B3 (fr)
WO (1) WO2017005332A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102018210370A1 (de) * 2018-06-26 2020-01-02 Irubis Gmbh Einweg-Bioreaktor und dessen Verwendung

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005111602A2 (fr) * 2004-05-07 2005-11-24 Sensicore, Inc. Système multicapteur pour la surveillance de fluides avec exposition sélective des capteurs
US20050272146A1 (en) * 2004-06-04 2005-12-08 Geoffrey Hodge Disposable bioreactor systems and methods
WO2013052836A1 (fr) * 2011-10-07 2013-04-11 Atmi Packaging, Inc. Système de commande de traitement de liquide et procédés connexes

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9575087B2 (en) * 2012-09-06 2017-02-21 Parker-Hannifin Corporation Risk-managed, single-use, pre-calibrated, pre-sterilized sensors for use in bio-processing applications
US8817259B2 (en) * 2011-03-25 2014-08-26 Parker-Hannifin Corporation Optical sensors for monitoring biopharmaceutical solutions in single-use containers
US9970984B2 (en) * 2011-12-01 2018-05-15 Life Technologies Corporation Method and apparatus for identifying defects in a chemical sensor array
US9410626B2 (en) * 2013-07-24 2016-08-09 Pall Corporation Sensor probe seal

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005111602A2 (fr) * 2004-05-07 2005-11-24 Sensicore, Inc. Système multicapteur pour la surveillance de fluides avec exposition sélective des capteurs
US20050272146A1 (en) * 2004-06-04 2005-12-08 Geoffrey Hodge Disposable bioreactor systems and methods
WO2013052836A1 (fr) * 2011-10-07 2013-04-11 Atmi Packaging, Inc. Système de commande de traitement de liquide et procédés connexes

Also Published As

Publication number Publication date
EP3319727B1 (fr) 2019-05-08
US10968421B2 (en) 2021-04-06
US20190002810A1 (en) 2019-01-03
DE102015110894B3 (de) 2016-09-01
CN107636138A (zh) 2018-01-26
CN107636138B (zh) 2021-03-05
EP3319727A1 (fr) 2018-05-16

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